This product is classified as an FDA-regulated compound under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Quality and Security Act (DQSA), Title I — Compounding Quality Act (2013).
MedTech Research Group will only fulfill orders for this compound to state-licensed 503A compounding pharmacies or FDA-registered 503B outsourcing facilities that maintain current registration with the U.S. Food and Drug Administration.
Verification Requirements
- Valid state pharmacy license (verified against state board of pharmacy records)
- Current state licensure (503A) or FDA registration (503B) verified via the appropriate state board of pharmacy or FDA Drug Establishment Registration database
- DEA registration (if applicable to the compound)
- Compliance with current Good Manufacturing Practice (cGMP) per 21 CFR Parts 210 and 211
This product may not be sold to consumers, wellness clinics, health stores, or any entity not licensed as a compounding pharmacy. Orders will not be fulfilled until licensure verification is complete. Ref: 21 U.S.C. §§ 353a, 353b; FDA Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products (2025).
